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NCT01997840 · ClinicalTrials.gov registry record · Phase 1
ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma
A Phase 1 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
NCT01997840: Clinical Trial Phase 1 study, sponsored by Celgene.
NCT01997840 is a Phase 1 study that was terminated before completion, run by Celgene. The registered enrollment target is 103 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01997840, a Phase 1 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
Study Summary
Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in combination with Pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma. Phase 2: To determine the overall response rate of ACY-1215 in combination with Pomolidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma
Primary Outcome
The maximum tolerated dose (MTD) was defined as the highest dose level at which no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) within the first 28-day cycle. If no more than 1 of these 6 patients experienced a DLT within the first 28-day cycle, then the last dose level enrolled to meet these criteria was identified as the recommended dose for the Phase 2 segment of the study.
Interventions
- DRUG ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2024-02-29 |
| Phase | Phase 1 |
Why NCT01997840 stopped before completion
NCT01997840 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 1 intervention - of which ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone is the first listed.
NCT01997840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01997840 about?
NCT01997840 is a clinical study titled "ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma". Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in combination with Pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma. Phase 2: To determine the overall response rate of ACY-1215 in combination with Pomolidomide and low-...
What is the current status of trial NCT01997840?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2014-03-01. Estimated completion is 2024-02-29.
What interventions are being tested in trial NCT01997840?
The interventions under investigation include: ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01997840?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01997840's enrollment target sits among peer trials
103 541st of 2000 higher than 1,458 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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